Sr. Program Manager

Sr. Program Manager

We are seeking an experienced Senior Program Manager to oversee and drive cross-functional development programs for small molecule therapeutics. This role will provide leadership and coordination across CMC, non-clinical, clinical, and regulatory functions, ensuring that programs are executed on time, within budget, and in compliance with global regulatory standards.

The Senior Program Manager will serve as the primary point of accountability for assigned programs, leading integrated teams, and reporting progress and risks to executive leadership. The ideal candidate brings broad drug development expertise, strong organizational skills, and the ability to influence and motivate diverse stakeholders to achieve program goals.

Roles and responsibilities include:

• Leading cross-functional teams through all stages of small molecule drug development, from preclinical through late-stage clinical studies
• Driving end-to-end program lifecycle – initiation to closure – ensuring stakeholder alignment and objective clarity
• Overseeing CMC timelines and deliverable completion for activities that include process development, manufacturing, analytical methods, formulation, stability, and clinical supply readiness across multiple suppliers to ensure that materials are delivered on time and within budget
• Coordinating with Nonclinical activities such as toxicology, PK/PD, safety pharmacology, and ADME studies to enable on time regulatory submissions
• Partnering with Regulatory Affairs to develop and implement regulatory strategy toward NDA completion and submission
• Developing and maintaining integrated project plans covering scope, timelines, budgets, resources, and risk management strategies
• Tracking progress against milestones, anticipating issues, and implementing corrective actions when necessary
• Providing clear, concise updates and presentations to executive leadership, governance committees, and external stakeholders
• Identifying and mitigating program risks across technical, regulatory, operational, and financial dimensions.

Qualifications

Basic qualifications include:

• Advanced degree in life sciences, pharmaceutical sciences, or related field (PhD, PharmD, MS, or equivalent strongly preferred).
• Minimum of 8 years of experience in the pharmaceutical/biotech industry, with at least 5 years in program management.
• Proven track record managing small molecule development programs through IND-enabling studies and clinical phases to NDA Submission.
• Experience with CMC, regulatory submissions, clinical operations, and non-clinical activities.
• Strong understanding of the drug development lifecycle, from discovery through commercialization.
• Familiarity with global regulatory requirements (FDA, EMA, ICH guidelines) and compliance standards (GxP).
• Advanced program management skills with experience in budgeting, forecasting, and scenario planning.
• Ability to communicate complex issues clearly to both technical teams and executive leadership.
• Strategic thinker with excellent problem-solving, organizational, and risk management capabilities.
• Strong interpersonal skills with a demonstrated ability to influence without authority to deliver broad impact
• Experience working with senior leadership and presenting to executive stakeholders
• Excellent written and verbal communication skills; able to synthesize complex topics into clear, actionable plans
• Highly motivated, detail-oriented, and adaptable in fast-paced, dynamic environments

Preferred qualifications include:

• Prior experience in biopharmaceutical launch
• Project Management Professional (PMP) certification is preferred.
• Knowledge of Design Controls under US and International Regulations preferred.
• Proven ability to think strategically, plan and align product development with business goals and market needs.
• Naturally accountable, a self-starter, self-motivated, self-directed, self-sustaining.
• Outstanding communication and presentation skills, written and verbal, to all levels of an organization.